Evaluation and Optimization of the Technical and Clinical Performance of the Lumenis ONE Platform

Port Wine Stain Clinical Trial

Official title:

Evaluation and Optimization of the Technical and Clinical Performance of the Lumenis ONE Platform

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00247299
• Other study ID #: danaCTIL
• Secondary ID: danaCTIL
• Status: Active, not recruiting
• Phase: N/A
• First received: October 30, 2005
• Last updated: October 30, 2005
• Start date: May 2005

Study information

• Verified date: October 2005
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

The Intense Pulsed Light (IPL) technology, by selective phototermolysis, is used for eliminating, among other application, benign vascular lesions and unwanted leg veins. Light energy heats the deeper structures of the skin. IPL devices provide a broad wavelength spectrum of 515 to 1200 nm and fluence from 10 to 40 J/cm at o.5-1 Hz.The light is focused by a reflector and then transmitted through various filters that cut off the lower wavelength range of the emitted light; therefore, only those wavelengths longer than these of the filters are transmitted.

objectives:

1. evaluate and optimize the clinical performance of the Luminis ONE platform for each of the aforementioned clinical applications.

2. Reconfirm the parameter settings for each of the aforementioned clinical applications.

3. Confirm the user friendly design of the device, in aspects of software (user interface) and various technical operational features.

Description:

Background:

The Intense Pulsed Light (IPL) technology, by selective phototermolysis, is used for eliminating, among other application, benign vascular lesions and unwanted leg veins. Light energy heats the deeper structures of the skin. IPL devices provide a broad wavelength spectrum of 515 to 1200 nm and fluence from 10 to 40 J/cm at o.5-1 Hz.The light is focused by a reflector and then transmitted through various filters that cut off the lower wavelength range of the emitted light; therefore, only those wavelegths longer than these of the filters are transmitted.

Material and Methods:

The luminis ONE medical system (Lumenis Ltd., Yokneam,Israel, and Pleasanton, CA, USA) incorporate the non coherent pulsed light head.

Vascular lesion such as Telangiectases, leg veins or PWS will be treated with the IPL, with the following filters :515,50,or 590.

Following every treatment the subjects will be asked how much pain was felt , using a score of 1-5.

Photographs will be taken before each treatments . Every subject will be treated 5 treatments , with 5+1 weeks interval. clearance or improvement will be evaluated by the physician at each visit,before the next treatment using the following scale:

1. No clearance

2. 0-25%

3. 25-50%

4. 50-75%

5. 75-100%

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy Subjects, presenting with at least one of the clinical indications mentioned above

• Willing and being able to comply with all visit and evaluation requirements

• Willing and being able to provide signed Informed Consent

Exclusion Criteria:

• A history of keloid scar formation or poor wound healing

• Wounded or tanned in area to be treated

• Pregnant or intending to become pregnant during the evaluation period

• Subjects with a bleeding disorder or who take anticoagulation medications

• Significant concurrent illnesses, such as diabetes, epilepsy, lupus or congestive heart failure

• Significant concurrent skin conditions affecting area to be treated

• Having a history of skin cancer or any other cancer in the area to be treated

• History of immunosuppressive disease

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemangioma, Capillary
• Port Wine Stain
• Port-Wine Stain
• Telangiectases
• Telangiectasis

Intervention

Device:
• IPL Quantum Product manufactured by Luminis Ltd.

Locations

Country	Name	City	State
Israel	Plastic surgery dept., Rambam medical center	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Rambam Health Care Campus	Lumenis Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Every subject will be treated 5 treatments , with 5+1 weeks interval.
Primary	clearance or improvement will be evaluated by the physician at each visit,before the next treatment using the following scale:
Primary	1. No clearance
Primary	2. 0-25%
Primary	3. 25-50%
Primary	4. 50-75%
Primary	5. 75-100%